BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1913765 · Received November 23, 2010

    Report

    Report Number
    2027969-2010-02031
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 7.0, LAB: 15.36; (B)(6) 2010, 7.2, 18. TESTS WERE DRAWN/RUN WITHIN 5 MINUTES OF EACH OTHER. CUSTOMER IS NOT SURE WHICH STRIP LOT WAS USED FOR THE DATA PROVIDED. NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1